PROJECT SUMMARY/ABSTRACT: CairnSurgical LLC, a Dartmouth spin-off company, will optimize and test multi-site clinical feasibility of a new image-guided intervention device, the Breast Cancer Locator (BCL), in breast conserving surgery (BCS) to (i) eliminate wire localization - a moderately effective, somewhat costly and certainly inconvenient procedure for patients and surgeons - and concomitantly to (ii) reduce positive margin rates and subsequent re-excision surgeries - a significant but unnecessary burden not only on patients but also on the cost of healthcare. Specifically, BCL is a patient-specific, 3D printed device that allows accurate clinical transfer of multiple surgical cues not available through other competing technologies currently available, including i) a tumor silhouette projected on the breast surface as viewed from the incision site, ii) an intra-operatively placed wire that defines a direct path to the tumor from the incision site, iii) interstitial inking of the maximum tumor extents using an innovative system of access ports, and 4) distances from the anterior tumor edge to breast surface and the posterior tumor edge to the chest wall. In the proposed Phase II studies, CairnSurgical will collaborate with Dartmouth researchers and surgeons at four partnering institutions to 1) improve BCL model creation process efficiency by eliminating the need for optical scanning and clinically validate the approach in a 10- patient study at Dartmouth, 2) develop BCLPlanner software to streamline BCL creation and quality assurance processes, and optimize BCL production, packaging and delivery to achieve manufacturing and scale-up efficiencies, and 3) test the feasibility of BCL at four distant clinical sites in approximately 12 patients with palpable breast cancers. Quality assurance and validation data (both clinical and non-clinical) obtained from these studies will support 510(k) regulatory filing for the BCL device. Positive margin rates associated with contemporary BCS are high (~22%-42%)9-13, and cause significant strains on patients and the cost of breast healthcare. Meta-analyses of the impact of surgical margins on local recurrence also confirm that negative margins have a positive prognostic effect. Thus, CairnSurgical is well positioned to explore and commercially develop a potentially practice-changing approach to BCS for accurate resection of breast cancers.